Curative-Korva SARS-Cov-2 Assay, Emergency Use Authorization (April 16, 2020)

Summary

In this April 16, 2020 letter to Curative Inc. Chief Executive Officer Fred Turner, the FDA authorizes emergency use of the Curative-Korva SARS-Cov-2 Assay, made by KorvaLabs, Inc., under section 564 of the Federal Food, Drug, and Cosmetic Act. It relies on the February 4, 2020 determination by the Secretary of Health and Human Services that a public health emergency exists involving the virus that causes COVID-19. The authorization is limited to qualitative detection of SARS-CoV-2 nucleic acid in throat, nasopharyngeal and nasal swabs and oral fluid specimens from individuals suspected of COVID-19 by their healthcare provider. Use is limited to KorvaLabs, which is CLIA-certified for high complexity tests, and the EUA lasts until the declaration is terminated or the authorization revoked. The letter is signed by RADM Denise M. Hinton, Chief Scientist.

Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used

Full text

April 16, 2020

Fred Turner
Chief Executive Officer
Curative Inc.
1600 Adams Drive, Suite 105
Menlo Park, CA 94025

Device: Curative-Korva SARS-Cov-2 Assay
Company: KorvaLabs, Inc.
Indication:
D
Qualitative detection of nucleic acid from SARS-CoV-2 in
oropharyngeal (throat) swab, nasopharyngeal swab, nasal swab,

KE
and oral fluid specimens from individuals suspected of COVID-19
by their healthcare provider. Emergency use of this test is limited
to KorvaLabs, Inc. that is certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to
perform high complexity tests (“authorized laboratory”).

Dear Mr. Turner:
O
R
This letter is in response to your1 request that the Food and Drug Administration (FDA) issue an

EV
Emergency Use Authorization (EUA) for emergency use of your product,2 pursuant to Section
564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the
Department of Health and Human Services (HHS) determined that there is a public health
emergency that has a significant potential to affect national security or the health and security of
United States citizens living abroad, and that involves the virus that causes COVID-19.
Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of
HHS then declared that circumstances exist justifying the authorization of emergency use of in
vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the
terms of any authorization issued under Section 564(a) of the Act.3

1
For ease of reference, this letter will use the term “you” and related terms to refer to KorvaLabs, Inc.
2
For ease of reference, this letter will use the term “your product” to refer to the Curative-Korva SARS-Cov-2
Assay used for the indication identified above.
3
U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration
that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 360bbb-3. 85 FR 7316 (February 7, 2020).
Page 2 – Fred Turner, KorvaLabs, Inc.

Having concluded that the criteria for issuance of this authorization under Section 564(c) of the
Act are met, I am authorizing the emergency use of your product, described in the Scope of
Authorization section of this letter (Section II), subject to the terms of this authorization.

I. Criteria for Issuance of Authorization

I have concluded that the emergency use of your product meets the criteria for issuance of an
authorization under Section 564(c) of the Act, because I have concluded that:

1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this virus;

2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe
that your product may be effective in diagnosing COVID-19, and that the known and
potential benefits of your product when used for diagnosing COVID-19, outweigh the
known and potential risks of your product; and

D
3. There is no adequate, approved, and available alternative to the emergency use of your
product. 4

II. Scope of Authorization
KE
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is
limited to the indication above.

Authorized Product Details O
R
Your product is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in
oropharyngeal (throat) swab, nasopharyngeal swab, nasal swab, and oral fluid specimens from

EV
individuals suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 nucleic acid
is generally detectable in respiratory specimens during the acute phase of infection. Positive
results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with
patient history and other diagnostic information is necessary to determine patient infection status.
Positive results do not rule out bacterial infection or co-infection with other viruses.

To use your product, SARS-CoV-2 nucleic acid is first extracted, isolated and purified from
oropharyngeal (throat) swab, nasopharyngeal swab, nasal swab, and oral fluid specimens. The
purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and
detection using an authorized real-time (RT) PCR instrument. The Curative-Korva SARS-Cov-2
Assay uses all commercially sourced materials or other authorized materials and authorized
ancillary reagents commonly used in clinical laboratories as described in the authorized
procedures submitted as part of the EUA request.

Your product requires the following control materials, or other authorized control materials, that
are processed in the same way as the patient specimens and are required to be included with each
batch of specimens tested with your product. All controls listed below must generate expected

4
No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
Page 3 – Fred Turner, KorvaLabs, Inc.

results in order for a test to be considered valid, as outlined in the authorized procedures
submitted as part of the EUA request:

· RP Positive Extraction Control: RNase P (RP) control in clinical samples: serves as a
positive extraction control for each sample. It also confirms the absence of PCR
inhibitors in each eluted RNA sample.
· SARS-CoV-2 and RP Positive Process Control: This control monitors the success of
the RNA extraction and confirms the performance of the RT-PCR master mix. The
positive process control consists of uninfected collection media spiked with
quantified nCoV plasmid and Hs_RPP30 gene.
· Negative Process Control: The negative process control consists of uninfected
collection media, and two replicates are processed with every extraction batch run.

Your product also requires the use of additional authorized materials and authorized ancillary
reagents that are not included with your product and are described in the EUA summary.

D
The above described product, when labeled consistently with the authorized procedures
submitted as part of the EUA request, and as described in the EUA summary (available at

KE
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-
authorizations), which may be revised in consultation with, and with concurrence of, the
Division of Microbiology Devices (DMD)/Office of Health Technology 7 Office of In Vitro
Diagnostics and Radiological Health (OHT7-OIR)/Office of Product Evaluation and Quality
(OPEQ)/Center for Devices and Radiological Health (CDRH), is authorized to be distributed to

O
and used by authorized laboratories under this EUA, despite the fact that it does not meet certain
requirements otherwise required by applicable federal law.

R
Your product is authorized to be accompanied by the following product-specific information
pertaining to the emergency use, which is required to be made available to healthcare providers

EV
and patients:

·
·
Fact Sheet for Healthcare Providers: Curative-Korva SARS-Cov-2 Assay
Fact Sheet for Patients: Curative-Korva SARS-Cov-2 Assay

I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that
the known and potential benefits of your authorized product, when used for the qualitative
detection of SARS-CoV-2 and used consistently with the Scope of Authorization of this letter
(Section II), outweigh the known and potential risks of your product.

I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific
evidence available to FDA, that it is reasonable to believe that your product may be effective for
the indication above, when used consistently with the Scope of Authorization of this letter
(Section II), pursuant to Section 564(c)(2)(A) of the Act.

FDA has reviewed the scientific information available to FDA, including the information
supporting the conclusions described in Section I above, and concludes that your product (as
described in the Scope of Authorization of this letter (Section II)) meets the criteria set forth in
Page 4 – Fred Turner, KorvaLabs, Inc.

Section 564(c) of the Act concerning safety and potential effectiveness.

The emergency use of your product under this EUA must be consistent with, and may not
exceed, the terms of this letter, including the Scope of Authorization (Section II) and the
Conditions of Authorization (Section IV). Subject to the terms of this EUA and under the
circumstances set forth in the Secretary of HHS's determination under Section 564(b)(1)(C)
described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1),
your product is authorized for the indication above.

This EUA will cease to be effective when the HHS declaration that circumstances exist to justify
the EUA is terminated under Section 564(b)(2) of the Act or when the EUA is revoked under
Section 564(g) of the Act.

III. Waiver of Certain Requirements

I am waiving the following requirements for your product during the duration of this EUA:

· D
Current good manufacturing practice requirements, including the quality system
requirements under 21 CFR Part 820 with respect to the design, manufacture,

KE
packaging, labeling, storage, and distribution of your product.

IV. Conditions of Authorization

Pursuant to Section 564(e) of the Act, I am establishing the following conditions on this
authorization:
O
R
KorvaLabs, Inc.

EV
A. Your product must comply with the following labeling requirements under FDA
regulations: the intended use statement (21 CFR 809.10(a)(2), (b)(2)); adequate
directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5), (7), and (8)); any appropriate
limitations on the use of the device including information required under 21 CFR
809.10(a)(4); and any available information regarding performance of the device,
including requirements under 21 CFR 809.10(b)(12).

B. You will inform relevant public health authorities of this EUA, including the terms and
conditions herein, and any updates made to your product, authorized labeling and
authorized Fact Sheets.

C. You will notify the relevant public health authorities of your intent to run your product.

D. You will have a process in place for reporting test results to healthcare providers and
relevant public health authorities, as appropriate.

E. You will include with test result reports, all authorized Fact Sheets. Under exigent
circumstances, other appropriate methods for disseminating these Fact Sheets may be
Page 5 – Fred Turner, KorvaLabs, Inc.

used, which may include mass media.

F. You will make available on your website(s) the Fact Sheet for Healthcare Providers
and the Fact Sheet for Patients.

G. You are authorized to make available additional information relating to the emergency
use of your product that is consistent with, and does not exceed, the terms of this letter
of authorization.

H. You will use your product as outlined in the authorized procedures submitted as part of
the EUA request. Deviations from the authorized procedures, including the authorized
instruments, authorized extraction methods, authorized clinical specimen types,
authorized control materials, authorized other ancillary reagents and authorized
materials required to use your product are not permitted.

I. You will collect information on the performance of your product. You will report to

D
DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-Reporting@fda.hhs.gov)
any suspected occurrence of false positive or false negative results and significant
deviations from the established performance characteristics of your product of which
you become aware.
KE
J. You may request changes to the Scope of Authorization (Section II in this letter) of your
product. Such requests will be made in consultation with DMD/OHT7-

O
OIR/OPEQ/CDRH, and require concurrence of, Office of Counterterrorism and
Emerging Threats (OCET)/Office of the Chief Scientist (OCS)/Office of the
Commissioner (OC) and DMD/OHT7-OIR/OPEQ/CDRH.

R
K. You may request changes to the authorized labeling. Such requests will be made in

EV
consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.

L. You may request changes to the authorized Fact Sheets. Such requests will be made in
consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.

M. You may request the addition of other instruments and associated software for use with
your product. Such requests will be made in consultation with, and require concurrence
of, DMD/OHT7-OIR/OPEQ/CDRH.

N. You may request the addition of other extraction methods for use with your product.
Such requests will be made in consultation with, and require concurrence of,
DMD/OHT7-OIR/OPEQ/CDRH.

O. You may request the addition of other specimen types for use with your product. Such
requests will be made in consultation with, and require concurrence of, DMD/OHT7-
OIR/OPEQ/CDRH.
Page 6 – Fred Turner, KorvaLabs, Inc.

P. You may request the addition and/or substitution of primers or probes for use with your
product. Such requests will be made in consultation with, and require concurrence of,
DMD/OHT7-OIR/OPEQ/CDRH.

Q. You may request the addition and/or substitution of control materials for use with your
product. Such requests will be made in consultation with, and require concurrence of,
DMD/OHT7-OIR/OPEQ/CDRH.

R. You may request the addition and/or substitution of other ancillary reagents and
materials for use with your product. Such requests will be made in consultation with,
and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.

S. You will evaluate the analytical limit of detection and assess traceability5 of your
product with any FDA-recommended reference material(s). After submission to FDA
and DMD/OHT7-OIR/OPEQ/CDRH’s review of and concurrence with the data, You
will update its labeling to reflect the additional testing. Such labeling updates will be

D
made in consultation with, and require concurrence of, DMD/OHT7-
OIR/OPEQ/CDRH.

KE
T. You will track adverse events, including any occurrence of false results and report to
FDA under 21 CFR Part 803.

U. All laboratory personnel using your product must be appropriately trained in RT-PCR

O
techniques and use appropriate laboratory and personal protective equipment when
handling this kit, and use your product in accordance with the authorized labeling.

R
V. You will maintain records of test usage and ensure that any records associated with this
EUA are maintained until otherwise notified by FDA. Such records will be made

EV
available to FDA for inspection upon request.

Conditions Related to Advertising and Promotion

W. All advertising and promotional descriptive printed matter relating to the use of your
product shall be consistent with the Fact Sheets and authorized labeling, as well as the
terms set forth in this EUA and the applicable requirements set forth in the Act and FDA
regulations.

X. All advertising and promotional descriptive printed matter relating to the use of your
product shall clearly and conspicuously state that:

· This test has not been FDA cleared or approved;

· This test has been authorized by FDA under an EUA for use by authorized
laboratories;

5
Traceability refers to tracing analytical sensitivity/reactivity back to an FDA-recommended reference material.
Page 7 – Fred Turner, KorvaLabs, Inc.

· This test has been authorized only for the detection of nucleic acid from SARS-
CoV-2, not for any other viruses or pathogens; and,

· This test is only authorized for the duration of the declaration that circumstances
exist justifying the authorization of emergency use of in vitro diagnostics for
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21
U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked
sooner.

No advertising or promotional descriptive printed matter relating to the use of your product
may represent or suggest that this test is safe or effective for the detection of SARS-CoV-2.

The emergency use of your product as described in this letter of authorization must comply
with the conditions and all other terms of this authorization.

V. Duration of Authorization
D
This EUA will be effective until the declaration that circumstances exist justifying the

KE
authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of
COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under
Section 564(g) of the Act.

O
REV
Sincerely,

____________________________
RADM Denise M. Hinton
Chief Scientist
Food and Drug Administration

Enclosures

File and source

File: d05-07a.pdf
Size: 2,897,642 bytes
SHA-256: e585ea7ec4769a375bf5e027d390db18128a063a808dc3c0f70d027b6017ef1a
Our copy: d05-07a.pdf
Original: www.fda.gov